AstraZeneca (AZN) Asthma Candidate Meets Primary Study Goals Leave a comment


AstraZeneca AZN announced that two phase III studies (MANDALA and DENALI) evaluating its investigational dual combination inhaler, PT027, for asthma achieved all primary endpoints.

Developed by the company in collaboration with Avillion, PT027 is a fixed-dose combination of albuterol and budesonide. While albuterol is a short-acting beta2-agonist, budesonide is an inhaled corticosteroid.

Data from the studies demonstrated significant benefits of PT027 at both doses of 180/160mcg and 180/80mcg in asthma patients compared with individual components of the candidate – albuterol and budesonide. The safety profile of the candidate was consistent with the known profiles of the individual components.

The company’s stock has rallied 12.6% so far this year in comparison with the industry’s 10.7% increase.

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While the MANDALA study evaluated PT027 as a rescue medicine in response to symptoms in moderate to severe asthma patients against albuterol, the DENALI study evaluated the candidate in second-line treatment of mild to moderate asthma against individual components – albuterol and budesonide as well as placebo. Data from the MANDALA study demonstrated that PT027 significantly reduced the risk of severe asthma exacerbation in patients compared to albuterol. Data from the DENALI study demonstrated significant improvement in lung function in PT027-administered patients in response to individual components, albuterol and budesonide.

Please note that the doses of the candidate and individual components were administered to patients enrolled in the study in a pressurised metered-dose inhaler using AstraZeneca’s Aerosphere delivery technology.

The safety profile of the inhaler was also consistent with the known profiles of the individual components. The company anticipates divulging details of the studies at a future medical meeting.

Per the collaboration terms, Avillion became the study sponsor responsible for funding PT027 through a regulatory decision in the United States, while AstraZeneca has the option of commercializing the candidate in the country, once approved.

If approved, the drug will face stiff competition from Glaxo’s GSK Trelegy Ellipta, which received approval from the FDA to treat asthma indication in adults in September 2020. The drug is already marketed to treat chronic obstructive pulmonary disease. The medicine has demonstrated an encouraging uptake since approval for asthma indication.

In a separate press release, AstraZeneca announced that it has presented detailed data from the phase III POSEIDON study at the 2021 World Conference on Lung Cancer. The POSEIDON study evaluated the company’s drugs Imfinzi and tremelimumab in combination with platinum-based chemotherapy in first-line treatment of patients with metastatic non-small cell lung cancer. Data from the study showed that Imfinzi and tremelimumab with chemotherapy improved progression-free survival by 28% as well as overall survival by 23% compared to chemotherapy alone in the above-mentioned patient group.

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Zacks Rank & Stocks to Consider

AstraZeneca currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the biotech sector include Moderna MRNA and Regeneron Pharmaceuticals REGN, each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Moderna’s earnings per share estimates for 2021 have increased from $24.71 to $29.21 in the past 60 days. The same for 2022 has risen from $17.83 to $25.44 over the same period. The stock has rallied 336.4% in the year so far.

Regeneron’s earnings per share estimates for 2021 have increased from $49.53 to $54.15 in the past 60 days. The same for 2022 has risen from $41.35 to $44.11 over the same period. The stock has rallied 33.7% in the year so far.

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